Especialista De Calidad

Work Your Magic with us Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. We are looking for a Quality Specialist to support regulatory compliance activities, reporting to the Quality Manager. This role ensures alignment with COFEPRIS regulations (NOM-059, NOM-072, NOM-240, NOM-241), GMP / GDP standards, and audit readiness. YOUR ROL : Ensure compliance with local health regulations and support COFEPRIS inspections. Manage deviations, CAPAs, complaints, change controls, and product alerts. Maintain and improve the Quality Management System (QMS) using TrackWise, SAP, and Power BI. Oversee warehouse and logistics operations : inspections, calibrations, relabeling, and storage compliance. Coordinate product release, returns handling, and lifecycle management. Support validation (equipment, cold chain) and pharmacovigilance reporting. Conduct audits of clients and suppliers to ensure compliance. Deliver GxP training and contribute to crisis and recall management. WHO YOU ARE : Degree in Pharmacy, Chemistry, or related field (QFB, QFI). 4-9+ years' experience in pharmaceutical quality or regulatory roles. Proven experience with GMP, GDP, COFEPRIS, and client / supplier audits. Strong organizational, communication, and problem-solving skills. Self-driven and detail-oriented. Location : Cuautitlán Izcalli What we offer : We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress Notice on Fraudulent Job Offers Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. Applicant Profile WHAT WE OFFER Money makes the world go round. But at our company there's more than just financial rewards. We offer a range of attractive benefits to help you work your magic. Saving & Finacial Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year. We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future. Health & Wellness We offer comprehensive medical, dental, & vision coverage-including virtual care through Telehealth & free behavioral health counseling sessions through our Employee Assistance Program. We also offer a wellness incentive program and personalized support to help you navigate and use your benefits. Voluntary Benefits Our voluntary benefits provide additional protection from the high costs of healthcare not US Equal Employment Opportunities The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. #J-18808-Ljbffr